Legal claim filed against 23andMe for lack of evidence

3 December 2013

US personal genomics company 23andMe’s bad week continues with the filing of a class action lawsuit that accuses the company of marketing a test with results unsupported by scientific evidence and via misleading claims.

The company stopped television, radio and online marketingof their Personal Genome Service (PGS) last week after receiving a warning letter from the FDA (see previous news).

US citizen Lisa Casey has filed the complaint with the Southern District Court of California. It says that PGS results are said to provide information about significant health issues such as diabetes, coronary heart disease and breast cancer, but cites the FDA letter as proof of 23andMe’s failure to provide analytical or clinical data in support of these marketed claims. It concludes that 23andMe marketing of the test over the last few years has been false, unfair and misleading, providing benefits solely to the company and to the detriment of those who purchased the service.

A class action is a legal case filed on behalf of a large number of potential claimants, on the basis that it would be impractical (and insanely expensive) for them to initiative separate legal claims. This particular complaint focuses on the loss of money by customers who have purchased a service alleged to be, essentially, fraudulent, and is seeking in excess of $5 million in damages.

Comment: The pressure was already on 23andMe to deliver scientific and clinical evidence in support of the claims made for the PGS testing. In addition to the loss of revenue from cessation of marketing and potentially also from reputational damage, this new legal case provides another strong motivation to produce the data. This of course does not necessarily mean that the gene variant – disease associations claimed by 23andMe were invalid, merely that the company has failed to provide adequate evidence to support them.

Assuming that the evidence does exist, the financial benefits of product launch in advance of delivery to the FDA could be swiftly eroded by these new developments. If, however, the company has failed to generate the data it requires, the situation is worse. Either way, it is safe to assume that both the scientific and legal teams are currently hard at work.